from the and-the-lawsuit-is-equally-questionable dept

Dr. Edward Tobinick was the subject of an LA Times article in 2013 -- I'd link to it, but it appears to have disappeared, though I don't know why -- which highlighted his (apparently now discontinued) practice of prescribing a particular drug, Enbrel, for Alzheimer's patients. Enbrel is approved for the treatment of arthritis. Steven Novella, a physician at Yale and who maintains the ScienceBasedMedicine blog which (you guessed it) focuses on playing up science-based medicine while criticizing more quackery-based medicine, wrote a critical blog post about Tobinick's practice. Novella carefully lays out his arguments as to why Tobinick appears to be engaged in what he believes is quackery. It's actually fairly even-handed, laying out various possibilities, and noting that there is some gray area for off-label uses of the drug. But then he points out that Tobinick appears to be making claims way beyond what any evidence supports:

The claims of Tobinick, however, are not in the gray area—they are leaps and bounds ahead of the evidence. Further, the conditions he claims to treat are not clearly immune-mediated diseases. It’s one thing to use an immune-suppressing drug to treat a disease that is known to be caused by immune activity, and probably the kind of immune activity suppressed by the drug.

Tobinick, however, is claiming that a wide range of neurological conditions not known to be immune mediated are treated by a specific immunosuppressant.

On his website he cites many studies, but none of them establish the effectiveness of Enbrel for any of the conditions he is treating. Most of them are simply identifying that TNF is increased in the condition. This is very weak evidence, however, as markers of immune activity are frequently increased in diseases that are not caused by immune activity. The immune system is very reactive—it reacts to disease with inflammation (often what we refer to as the cleanup crew). The inflammation is not causing the disease, it is simply the body’s reaction to it.

Tobinick was apparently upset about this and asked Novella to take down the blog post. Novella, quite reasonably, refused. Thirteen months later, Tobinick sued Novella and Yale University. Over what, you might ask? Well, there's clearly no defamation claim here, so Tobinick claims that Novella's blog post is an advertisement and represents "false advertising." He also claims that it's trademark infringement, and then demanded the blog post be taken down via an injunction. Novella is fighting back in court and on his blog. On the blog, he highlights the ridiculousness of Tobinick claiming this is an advertisement:

An interesting wrinkle of this suit is that Tobinick is claiming that my blog post is an “advertisement.” This is a legal maneuver as the threshold for forcing someone to remove an advertisement is much lower than the threshold for suppressing their free speech. I can only assume that he and his attorneys are not bothered by the fact that blog posts on SBM are blatantly not advertisements.

In the case of the Enbrel article he had to make the absurd claim that the post (which does not mention my own practice) was an advertisement for my neurology practice at Yale, designed to attack a “competitor.” He would have us believe that Yale neurology in Connecticut is concerned about a distant clinic. Further, Yale Neurology is an academic practice. Our problem is too many referrals and long wait times, not competitors. To see how desperate the claim is, he argued that because I use Botox, which can be used to treat symptoms following stroke, that his treatments for stroke represent a competitor. However, I don’t use Botox to treat stroke patients. I mostly use it to treat migraines, as I am a headache specialist.

From there, he digs in, with even more detail about his criticism of Tobinick's "practice."

Tobinick is not a neurologist, and yet he feels it is appropriate for him to treat multiple neurological conditions with an experimental treatment. It is generally considered unethical for physicians to practice outside of their area of competence and expertise. He is trained in internal medicine and dermatology and is certified in those specialties. He has never completed a neurology residency nor is he board certified in neurology.

Despite his lack of formal training and certification, he feels he has ushered in a “paradigm shift” in the treatment of Alzheimer’s disease – a disease that has proved challenging for actual neurologists for decades.

His treatment of choice is perispinal etanercept (Enbrel), which basically is an immunosuppressant drug. He is using this treatment for not only Alzheimer’s disease, but neurological deficits following stroke, traumatic brain injury, and pain resulting from vertebral discs. He therefore claims that the neurological deficits in these various conditions result from active inflammation (specifically tumor necrosis factor – TNF) and by inhibiting TNF “rapid improvement” in neurological function is possible.

These claims are highly implausible, and in my opinion reflect his lack of training and expertise as a neurologist. Strokes cause ischemic damage to the brain – brain cells in severe stroke die. Inflammation following stroke is incidental, not causative. Yet Tobinick claims that 10 years following a stroke, long after any neurological recovery would have occurred, patients can improve by inhibiting TNF.

He makes the same claim for Alzheimer’s disease, despite the fact that this is a neurodegenerative disease resulting in loss and destruction of brain cells. An anti-inflammatory drug is not going to bring back dead brain cells, yet he claims “rapid improvement” is possible.

There's more of that. The response to the request for the injunction, written by lawyer Marc Randazza is (in typical Randazza fashion) well worth the read. Here's just a snippet.

Dr. Novella’s critical opinions of the Plaintiffs are not outlier views. In fact, the
prevailing view seems to be that Dr. Tobnick is, at best, irresponsible. On the first page of
Google alone, there are numerous other articles written by other authors, entirely unrelated
to the article at hand, that also express critical and unflattering opinions of Tobinick and
Plaintiffs’ “medical” practices. For example, in 2008, The Alzheimer’s Forum published an
article criticizing Tobinick, his treatment of patients, and his self-promotional “studies.”
That article evaluated a paper published by Tobinick, in which he presented a study
involving one patient who purportedly improved his Alzheimer’s condition within minutes of
receiving Enbrel injections (as if such a thing were possible). The article’s author reached
out to seven independent researchers, who all “expressed unease about the way in which
these studies were performed.” Furthermore, in that article, Cynthia Lemere, associate
professor of Neurology at Bringham and Women’s Hospital in Boston stated “[t]his is
exciting, but very preliminary information. The appropriate way to pursue it at this stage is
to apply to FDA and NIH for support to run a rigorous trial, not to promote it to the
general public.” That article presented the opinion that Tobinick’s use of Enbrel gave false
hope to Alzheimer’s patients, without being based in scientific and clinical research, and
pointed to a number of fatal flaws in the case report authored by Tobinick.

More importantly, also on the first page of a Google search for “Dr. Tobinick” is an
article published by Casewatch.org, outlining the history of disciplinary action against
Tobinick in California, including the formal accusations filed by David Thorton as the
Executive Director of the Medical Board of California, Department of Consumer Affairs.
The stated allegations in the disciplinary action were for unprofessional conduct relating to
his advertisement of Enbrel for the treatment of neck and back pain, in violation of the
California Health and Safety Code, constituting unprofessional conduct. The second cause
of action was for Tobinick’s unprofessional conduct relating to his failure to obtain a permit
for use of “Institute of Neurological Research” as a fictitious name. The disciplinary action
was settled, resulting in a one-year probationary period for Tobinick, in lieu of the
revocation or suspension of his medical license and surgeon’s certificate, as proposed by
Thornton.

The response also takes on the ridiculousness of arguing that this is an "advertisement" and a trademark claim rather than an attempt to do an end run around defamation law.

Plaintiffs have cleverly attempted to disguise this defamation claim as a Lanham Act
claim – presumably to ensure the availability of Federal Court jurisdiction and to try to sidestep the clear case law that cuts against them in defamation actions. But, no matter how
eloquently someone may call a “dog” a “chicken,” it will never lay eggs. And styling a
specious defamation claim as a Lanham Act claim does not remove the underlying speech
from the protections afforded by the First Amendment.

Plaintiffs come to this Court seeking extraordinary relief in the form of an
impermissible prior restraint on Defendant’s speech because of allegedly “false advertising.”
Tobinick’s request for this exceptional relief is impermissible under the First Amendment,
and a request for this Court to impose a prior restraint on Defendant’s speech. “The clearest
definition of prior restraint is an administrative system or a judicial order that prevents speech from
occurring.” There has been no judicial determination as to whether Dr. Novella’s article is
“false,” nor whether it is “advertising.” (It is neither.) Yet, Plaintiffs come to this Court
requesting Constitutionally extraordinary relief – the suppression of speech without due
process. The motion must be denied.

So, the end result of a questionable, bogus SLAPP lawsuit in an attempt to silence a critic -- is much more attention paid to the original claims and other aspects of Tobinick's past.

That article evaluated a paper published by Tobinick, in which he presented a study involving one patient who purportedly improved his Alzheimer’s condition within minutes of receiving Enbrel injections (as if such a thing were possible).

This is actually very possible, and plausible even... and that's why it's unreliable. Drugs can very quickly decrease all sorts of symptoms. Just look at all the commercials you see that promise their product "offers immediate relief." So it's not at all doubtful that this patient started feeling better right away.

What's doubtful is that he stayed improved permanently, or even for any significant amount of time afterwards.

Malpractice makes perfect

What I always find to be most disturbing about any of these cases of obvious quackery, is that these people, regardless of the number of times they are cited for incompetence, irresponsibility, fraud and deception, just keep right on keeping on without pause, while the system that is supposed to protect citizens from such quacks continuously wrist-slaps them like they were simply slightly disobedient children.

There appears to be some unwritten rule that states it is improper to actually hold a doctor responsible for her/his actions. That doctors are special and should never be punished for their crimes, indeed, that their actions, no matter how heinous, should never be seen as crimes.

Chock another one up for a social system that apparently serves no-one but the top of the food chain.---

Google is power

Re: Re: Malpractice makes perfect

Understood.

Cops, when busted for criminal activity, get paid vacation time somewhere safely away from the press and their victims, while the force goes about doing everything it can to smear the reputations of the victims and make them appear to be criminals.

I've always said that any institution that lasts more than a decade will attract the attention of those who want to use the reputation it has earned, for nefarious purposes and once infiltrated by criminals will do everything it can to NOT fulfill its mandate and thus remain active eternally.

Any institution that lasts more than thirty years without fulfilling its mandate, was designed from the start to fail and thus remain active eternally.

The age of any institution that has failed to fulfill its mandate is thus the measure of its corruption.

The Institution of Law Enforcement has failed utterly at its purported mandate of preventing crime, and of its side mandate of catching criminals, so its corruption is likely complete.

During the first prohibition, the police were the first to become willing assistants of the mob. Drug Prohibition is far more lucrative and offers far greater reward to cops willing to turn their heads for graft. I assume the institution exists explicitly for the purpose of protecting the rich from the poor now.

I understand that in Canada, they actually have a Doctor's Lawyer Bank, paid for by taxpayers, whose purpose is specifically to prevent the public from ever charging any doctor with malpractice, by, among other things, finding ways to delay court proceedings over and over again until the angry victim-patient dies.

I assume there is something similar in the USA, but I've not read anything about such as yet. Perhaps its a little less "known" than Canada's, which I understand was never meant to become known.

Since the Illness Industry no longer has any desire to cure diseases but rather pretends to treat diseases via poison-based drug concoctions instead (which insures patients never get better and that they always need more and more drugs to combat side effects of the previous drugs), I assume its internal corruption is now as complete as is possible.

For instance, I understand the AMA no longer teaches new doctors about such North American parasites as Round Worm, Ring Worm and Pinworm, so these now go untreated, or should I say misdiagnosed and mis-treated as other disorders.

Perhaps the term "maltreated" would be more realistic.

The only redeeming note I can offer, is that this sort of thing has always been the way society works, and in truth, we the 99%, are indeed slightly ahead of the past eras as far as health is concerned. On the other hand, I think the powers that be are not pleased about that fact and are attempting to reverse it as soon as possible....